January 1,
2014: All new studies must be started in iRIS only. (Paper
forms and PATS applications will no longer be available for
any new submissions.)

January 1,
2014: The CITI requirements in iRIS will be modified. See
“New CITI Training Requirement” below.

Updated iRIS
Roll-out Schedule

Use of the
software is being phased in as outlined below:

Phases 1-2 (Current/Active): iRIS
is required for all new Exempt and Expedited applications
for submission to the East and West Campus IRBs.

Phase 3a
(Effective December 2013 Meetings): iRIS
is available for new Full Board applications
for submission to the East and West Campus IRBs for those
who want to take advantage of this opportunity. (Paper/PATS
submissions will still be accepted.)

Phase 3b
(Effective February 2014 Meetings):All
new Full board applications will only be accepted
via iRIS and will be assigned to the "next available
meeting." (Paper/PATS submissions will no longer be accepted
– please plan accordingly.)

Phase 4 (Schedule to be announced
shortly):Existing studies will be
“converted” to iRIS. Researchers,
please note that we will need your assistance to verify the
conversion data and add missing information in order to
proceed with subsequent IRB transactions such as Progress
Reports and Amendments.

Effective January 1, 2014, iRIS will verify completion of the
CITI Conflict of Interest module. Completion of both the COI
module and a human subjects course by all Key Personnel (including research coordinators) will be
required in order for submissions to be accepted by iRIS.

iRIS Tips

Get started
early. First time users need time to go through one-time
initialization steps (obtaining/verifying
username/password, activating iRIS account for each Key
Personnel, synchronizing CITI Training information, etc.)

Verify that
the PI and all Other Investigators have completed an
electronic COI disclosure within the last 90 days. (A list
of everyone's last COI date is available from the Help Menu
in iRIS.)

Verify that the PI and all Key Personnel have completed
CITI information in iRIS. (Submissions with
any KP missing CITI completion information are halted by
iRIS automatically and need to be retracted and resubmitted
once the problem is resolved.)

Track your
submission to ensure that signatories sign off promptly and
that it reaches the IRB.

The process of transitioning to the new iRIS
software will require extra effort on everyone’s part, but the
final outcome will yield significant benefits to the research
community. As we move forward, to assist with the transition,
there are user guides, optional training sessions,
and one-on-one assistance.

Some of the
many features and benefits of iRIS include:

Paperless submission (all study
documents are attached electronically and submitted
through the software).

Streamlined submission process.

Electronic signatures (applications
can be routed to PIs and chairs for electronic
sign-off/approval).

Dynamic application form (presents
relevant questions based on the answers you provide).

Multiple browser support (iRIS can be
accessed using most browsers from PCs and Macs).

Easy access to consents (all approved
(stamped) consent forms and other study documents will
be easily accessible in iRIS).

Single portal access (post
transition, researchers will be able access all of their
Einstein IRB (East and West) research protocols in one
place).

Full board protocols will be
assigned to the next available meeting (24/year).

Important changes to the submission process that coincide
with the release of iRIS: